Events

Recall of Device Recall Capsule Neuron UMPC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Capsule Tech Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58636
  • Event Risk Class
    Class 2
  • Event Number
    Z-2403-2011
  • Event Initiated Date
    2010-08-25
  • Event Date Posted
    2011-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99753
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MWI
  • Reason
    Software: data cached on the neuron due to server unavailability is not being delivered to the server after server availability is restored. if a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. batteries can discharge completely in a capsule neuron" umpc even though it is connected to power source.
  • Action
    Capsule Tech initiated three corrective action notifications for the Neuron" UMPC units three failure modes as follows: a) Data cached on the Capsule Neuron" UMPC due to server unavailability is not being delivered to the server after server availability is restored: i) A customer advisory was provided to a subset of consignees, along with DataCaptor software version 6.6.5 on December 1, 2010. ii) A customer advisory was provided to the remaining consignees, along with DataCaptor software version 6.6.7 on January 27, 2011. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes: i) A customer advisory was provided to all consignees on March 23, 2011, via phone call, email and FedEx;.The correction will be provided as a software update. A formal recall notification letter will be provided to all consignees alerting them to the availability of the correction once it is released, via phone call, email and FedEx. c) Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power. Note: the Capsule Neuron" UMPC operates normally when connected to power. i) A customer advisory was provided to all consignees on April 23, 2010, via FedEx. For questions regarding this recall contact Capsule technical support team at (800) 260-9537 or e-mail support@capsuletech.com..

Device

Device Recall Capsule Neuron UMPC
  • Model / Serial
    Serial Numbers: TS9800281 - TS9801370 TS9900645 - TS9900654 TS9B00103 - TS9B01109 TSA300737 - TSA301336 TSA600927 - TSA601526 TSA800623 - TSA801221 TSAA00335 - TSAA00338 TSAB01605 - TSAB02204 TSB300957 - TSB301460
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of Canada
  • Product Description
    Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. || Catalog Number: DC-NU-MPC || Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wired || Ethernet connection or via a standard 802.11 b/g/n wireless network, available in a fixed or mobile mounting option, running either DataCaptor continuous or periodic connectivity software || The DataCaptor" System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor" is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to
  • Manufacturer
    Capsule Tech Inc.

Manufacturer

Capsule Tech Inc.
  • Manufacturer Address
    Capsule Tech Inc., 300 Brickstone Sq, Andover MA 01810-1492
  • Source
    USFDA